FLANTADIN 6 mg Tablets

Зміст інструкції

1. Flantadin 6 mg tablets, 30 mg tablets, 22.75 mg/ml oral drops, suspension
   1. What Flantadin is and what it is used for
   2. What you need to know before taking Flantadin
   3. How to take Flantadin
   4. Possible side effects
   5. How to store Flantadin
   6. Contents of the pack and other information

Flantadin 6 mg tablets, 30 mg tablets, 22.75 mg/ml oral drops, suspension

deflazacort

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Flantadin is and what it is used for
• 2. What you need to know before you take Flantadin
• 3. How to take Flantadin
• 4. Possible side effects
• 5. How to store Flantadin
• 6. Contents of the pack and other information

1. What Flantadin is and what it is used for

Flantadin contains the active ingredient deflazacort, which belongs to the category of medicines called
corticosteroids (or glucocorticoids). Corticosteroids are produced naturally in our body and
contribute to regulating important processes for overall health.
Flantadin is used to treat inflammation and to reduce the response of the immune system (the system that
defends the body against viruses, bacteria, etc.) in certain diseases.
Flantadin is used to treat:

• disorders due to insufficient activity of the adrenal glands (primary and secondary adrenal insufficiency) (alone or in association with other medicines called mineralcorticoids);
• rheumatic diseases (psoriatic arthropathy, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, post-traumatic osteoarthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis);
• widespread diseases of the connective tissue (tissue that connects other tissues within the body) [systemic lupus erythematosus (SLE), acute rheumatic carditis (rheumatic heart disease), systemic dermatomyositis (polymyositis)];
• skin diseases [pemphigus, bullous herpetiform dermatitis, severe polymorphic erythema (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides (cutaneous lymphoma), severe psoriasis, severe seborrheic dermatitis];
• allergies (seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity);
• respiratory diseases [symptomatic sarcoidosis, berylliosis, fulminant or disseminated pulmonary tuberculosis (in association with appropriate chemotherapy), aspiration pneumonia];
• eye diseases due to severe, acute and chronic inflammatory and allergic processes (marginal corneal allergic ulcers, herpes zoster ophthalmicus, inflammation of the anterior segment of the eyeball,

choroiditis and diffuse posterior uveitis, sympathetic ophthalmitis, allergic conjunctivitis, keratitis, chorioretinitis,
optic nerve neuritis, iritis, and iridocyclitis);

• blood diseases, even with malignant evolution (secondary thrombocytopenia of the adult, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia; Hodgkin's disease, non-Hodgkin's lymphomas, chronic lymphocytic leukemia, acute leukemia of childhood, etc.);
• diseases characterized by fluid accumulation (idiopathic nephrotic syndrome of unknown or secondary origin, due to systemic lupus erythematosus);
• diseases of the stomach and intestines (ulcerative colitis, regional enteritis).

2. What you need to know before taking Flantadin

DO NOT take Flantadin

• if you are allergic to deflazacort or any of the other ingredients of this medicine (listed in section 6);
• if you have tuberculosis;
• if you have a peptic ulcer;
• if you have an eye infection due to herpes simplex;
• if you have fungal infections throughout the body;
• if you suffer from mental illnesses (psychosis);
• if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”);
• if the patient is in very early infancy, unless after careful evaluation by your doctor (see section “Children”).
• If you have been given a vaccine with live attenuated virus

Warnings and precautions
Consult your doctor or pharmacist before taking Flantadin.
Patients undergoing therapy for more than 3 weeks must carry with them the prescription for Flantadin treatment
and show it to any healthcare professional involved in the treatment.
Do not suddenly stop taking Flantadin, unless advised by your doctor.
Pay particular attention with Flantadin and inform your doctor:

• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking Flantadin or other medicines based on deflazacort. Severe skin reactions including toxic epidermal necrolysis have been reported in association with Flantadin treatment. Stop using Flantadin and consult your doctor immediately if you notice any of the symptoms described in section 4.
• if you have or have had particular stress: the doctor will adjust the dose taking into account the type of stress. Even if you have already stopped therapy for several months, the doctor will decide whether to continue or readminister the medicine or prescribe you adequate hormonal therapy. The dose must always be reduced gradually to limit impairment of adrenal gland function;
• if your thyroid gland is underactive (hypothyroidism);
• if you have a liver disease (hepatic cirrhosis);
• if you have tuberculosis: you can use Flantadin in cases of fulminant or generalized disease and together with appropriate treatment to cure tuberculosis. The doctor will keep you under close surveillance;
• if you have a form of inflammation with a risk of intestinal perforation (ulcerative colitis);
• if you have pus collections (abscesses) or infections that cause pus formation;
• if you have a disease caused by inflammation of part of the intestine (diverticulitis);
• if you have recently undergone surgery on the intestine (intestinal anastomoses);
• if you have a kidney disease (renal insufficiency);
• if you have high blood pressure;
• if you have diabetes;
• if you have a reduction in mineral content in the bones (osteoporosis);
• if you suffer from a disease that causes severe muscle weakness (myasthenia gravis);
• if you have an infection: corticosteroids can mask some signs of infection and infections can occur during their use that are added to the ongoing disease. In these cases, the doctor will assess whether to administer you an antibiotic;
• if you are to be vaccinated: during treatment with corticosteroids you should not be vaccinated;
• if you have or have had problems with emotional instability or a tendency to develop mental illnesses, as they can worsen during treatment. You may also experience: euphoria, difficulty sleeping (insomnia), mood or personality changes, severe depression or symptoms of genuine mental illnesses.
• if you come into contact with people affected by chickenpox or herpes zoster if you have not already contracted chickenpox before. People treated with Flantadin should take particular care to avoid exposure to measles and consult a doctor immediately if this should occur.

Prolonged use of Flantadin, like other glucocorticoids, can cause clouding of the natural lens
of the eye called a cataract, of the posterior subcapsular type, and an increase in intraocular pressure
(glaucoma) with possible damage to the optic nerves, and can increase the risk of eye infections
due to fungi or viruses.
Contact your doctor if you experience blurred vision or other visual disturbances.
In case of concomitant treatment with other medicines such as diuretics and beta agonists, the doctor may
prescribe blood tests to check certain parameters (potassium and blood pH).

Children
In very early infancy, the product should only be used in cases of actual necessity and under the direct control of
the doctor.
The doctor will carefully monitor the growth and development of children undergoing prolonged treatment.
The parents of a child treated with Flantadin who has not already contracted chickenpox and who comes into
contact with other children or people affected by chickenpox or herpes zoster must consult the
doctor immediately

Other medicines and Flantadin
Tell your doctor or pharmacist if you are taking, have recently taken other medicines, including
medicines obtained without a prescription.
Although no interactions with other medicines and incompatibilities with Flantadin are known, the doctor may
decide to increase the dose during concomitant treatment with:

• medicines to calm seizures (phenobarbital, diphenylhydantoin, carbamazepine);
• some antibiotics (rifampicin);
• medicines for the treatment of asthma and bronchopulmonary diseases (ephedrine).
• medicines to prevent blood clotting (warfarin)

The doctor may decide to reduce the dose during concomitant treatment with:

• other antibiotics (erythromycin, troleandomycin);
• medicines based on female hormones or preparations containing female hormones (estrogens).
• an antifungal medicine (ketoconazole)

Some medicines can increase the effects of Flantadin and the doctor may want to keep you under close
observation if you are taking these medicines (including some medicines for the treatment of HIV:
ritonavir, cobicistat).
If you have low levels of prothrombin in your blood (if you have blood clotting problems), the doctor will assess whether
it is appropriate to associate acetylsalicylic acid with corticosteroids such as Flantadin..
Antacids administered simultaneously to help digestion reduce intestinal absorption
of glucocorticoids such as Flantadin and consequently the symptoms of the disease for which it was prescribed
Flantadin may worsen.
The use of Flantadin may decrease the effectiveness of a sedative antipsychotic called quetiapine, reduce, as
other corticosteroids, the effectiveness of antibiotics during an infectious disease by altering the natural responses
of the body, counteract the effectiveness of drugs used for diabetes mellitus, including insulin, some
medicines used to control high blood pressure and diuretics, for which the doctor may decide whether
to modify or not the dosage of Flantadin.
The use of corticosteroids such as Flantadin can increase the effectiveness of anticoagulant therapy with warfarin or
other similar anticoagulant medicines called coumarins, for which it is necessary to monitor prothrombin time or INR to prevent bleeding; corticosteroids can also increase the activity of some
muscle relaxant medicines (non-depolarizing muscle relaxants) used during some surgical interventions,
increased activity that can determine prolonged muscle relaxation and acute muscle suffering.
In addition, corticosteroids such as Flantadin can accentuate the effect of reducing an element contained
in the blood, potassium, in conjunction with the use of medicines containing acetazolamide, some other
asthmatics (beta-2-agonists and theophylline) and a stomach lining protector
(carbenoxolone) which can independently determine a reduction in potassium in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, the medicine will only be prescribed to you in cases of actual
necessity and under the direct control of your doctor.
Do not take this medicine if you are pregnant or breastfeeding, unless after careful
evaluation by your doctor

Driving and operating machinery
To date, no effects of glucocorticoids on the ability to drive vehicles and operate machinery are known.

Flantadin 6 mg tablets contains lactose and sucrose
Flantadin 6 mg tablets contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to
some sugars, contact him before taking this medicine.

Flantadin 30 mg tablets contains lactose
Flantadin 30 mg tablets contains lactose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

Flantadin 22.75 mg/ml oral drops, suspension contains sorbitol
Flantadin 22.75 mg/ml oral drops, suspension contains 396 mg of sorbitol per maximum daily dose
(equivalent to 396 mg/3.96 ml).
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to some
sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which
patients are unable to transform fructose, talk to your doctor before you (or the child) take
this medicine.

Flantadin 22.75 mg/ml oral drops, suspension contains benzyl alcohol
Flantadin 22.75 mg/ml oral drops, suspension contains 0.039 ml of benzyl alcohol per maximum
daily dose (equivalent to 0.039 ml/3.96 ml).
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including respiratory problems (agonal breathing syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by your doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because large amounts
of benzyl alcohol can accumulate in the body and cause side effects (such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large
amounts of benzyl alcohol can accumulate in the body and cause side effects (such as acidosis
metabolic).

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in positive anti-doping tests.

3. How to take Flantadin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended initial dose in adults ranges from 6 to 90 mg (one or more tablets or more drops per
day), based on the severity and evolution of the disease to be treated.
The doctor will evaluate whether to maintain or modify the initial dose in order to obtain a satisfactory
response based on the disease and how you react to the treatment.
The maintenance dose must always be the minimum capable of controlling the symptoms.
The reduction of the dose must always be done little by little.
Take the daily dose of Flantadin in a single dose in the morning, together with small amounts of food.

Oral drops, suspension
Shake the bottle before use and dilute the suspension immediately before use in sugar water or
in non-carbonated beverages.
The suspension dropper delivers on average 1 mg of deflazacort per drop.

Use in children
In early infancy, the product should only be used in cases of actual necessity and under the direct control of the
doctor.
Children undergoing prolonged treatment with corticosteroids must be closely monitored from the
point of view of growth and development.

If you take more Flantadin than you should
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Flantadin
Do not take a double dose to make up for the missed dose.

If you stop taking Flantadin
Do not stop treatment abruptly. The doctor will tell you how to gradually reduce the dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with corticosteroids, such as Flantadin, especially for intensive and prolonged treatments,
some of the following side effects may occur with an unknown frequency:
Leukocytosis (increased white blood cells)
Heart failure (Inability of the heart to provide blood in an adequate quantity in relation to the body's needs)
Interference with the function of the pituitary-adrenal axis, particularly in times of stress; alteration of the
function of the endocrine glands (altered hormone production), changes in facial appearance (“moon face”), growth
disorders in children and adolescents. These side effects may be reduced by taking the tablets in a single dose in
the morning, if the treatment of the disease allows.
Posterior subcapsular cataract (progressive loss of transparency of the lens) and increased
intraocular pressure (inside the eye), chorioretinopathy (retinal disease), thinning
of the cornea or sclera, worsening of viral or fungal (mycotic) eye diseases. Blurred
vision with a rare frequency (which can affect up to 1 in 1,000 people).
Difficulty digesting food (dyspepsia), peptic ulcer of the stomach or duodenum (erosion of the inner lining of the
stomach and intestine), bleeding (hemorrhage), nausea, perforation of the peptic ulcer, acute pancreatitis
(especially in children), candidiasis (fungal infection).
Hypersensitivity (allergy), including anaphylaxis (a particular pathological reaction of an organism already sensitized
to a substance when the same substance is reintroduced).
Increased susceptibility to infections and severity with suppression of clinical signs and symptoms,
recurrence of latent tuberculosis. Candidiasis (fungal infection).
Negative nitrogen balance (decrease in the amount of body nitrogen due to reduced
muscle mass due to excessive metabolism); alterations of electrolyte balance including hypokalaemia
(reduced potassium in the blood) and hypernatremia (increased sodium in the blood)
weight gain
increased appetite
decreased glucose tolerance with possible manifestations of latent diabetes mellitus and increased
need for hypoglycemic drugs in diabetics to be determined at the doctor's discretion
alterations of electrolyte balance which, rarely and in particularly predisposed patients, can lead
to hypertension (high blood pressure) and cardiac pump failure
Osteoporosis (bone disease), bone fragility, myopathies (muscle diseases), vertebral and
long bone fractures; avascular necrosis ((death of bone tissue due to arrest of blood flow)),
tendinitis, tendon rupture in case of concomitant administration with quinolones (a type of antibiotic)
Dizziness, headache and increased intracranial pressure (around the brain); worsening
of epilepsy (neurological condition characterized by recurrent and sudden manifestations with sudden
loss of consciousness and violent muscle convulsions).
Psychiatric disorders of various kinds: irritability, anxiety, suicidal thoughts, mania, delusion, hallucinations,
worsening of schizophrenia, euphoria, insomnia, changes in mood or personality, severe
depression, cognitive disorders including confusion and amnesia (memory loss).
Menstrual irregularities

• Skin and subcutaneous tissue disorders

Delays in wound healing, thinning and fragility of the skin; hirsutism, acne, striae, ecchymoses
(blood infiltration under the skin), telangiectasias (dilation of small blood vessels, generally
superficial), edema (swelling). Severe skin rashes may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis) (frequency not known) within 8 weeks of starting treatment.

• Vascular disorders

Thromboembolism (formation of blood clots), particularly in patients with underlying conditions associated
with an increased tendency to thrombosis, hypertension in predisposed subjects.

• Respiratory, thoracic and mediastinal disorders

Hiccups.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Flantadin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flantadin contains
Flantadin 6 mg tablets

• The active ingredient is deflazacort. Each tablet contains 6 mg of deflazacort.
• The other ingredients are lactose, magnesium stearate, corn starch, microcrystalline cellulose, sucrose.

Flantadin 30 mg tablets

• The active ingredient is deflazacort. Each tablet contains 30 mg of deflazacort.
• The other ingredients are lactose, magnesium stearate, corn starch, microcrystalline cellulose.

Flantadin 22.75 mg/ml oral drops, suspension

• The active ingredient is deflazacort. 1 ml of suspension contains 22.75 mg of deflazacort.
• The other ingredients are aluminium and magnesium silicate, sodium carboxymethylcellulose, benzyl alcohol, sorbitol, polysorbate 80, acetic acid, purified water.

Description of the appearance of Flantadin and contents of the pack
Flantadin 6 mg tablets
Pack containing a blister of 10 tablets of 6 mg.
Flantadin 30 mg tablets
Pack containing a blister of 10 tablets of 30 mg.
Flantadin 22.75 mg/ml oral drops, suspension
13 ml bottle of suspension, with dropper.

Marketing Authorisation Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia